BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 16137084 · Received January 11, 2023

    Report

    Report Number
    2032227-2023-104138
    Event Type
    Injury
    Date Received
    January 11, 2023
    Date of Event
    January 2, 2023
    Report Date
    March 24, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283575
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE PUMP FOR ALLEGED PUMP ERROR 3 ALARM AND NO VIBRATION DURING THE SELF TEST FOUND ON (B)(6) 2023. THE PUMP PASSED THE ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT TEST AT .08715 INCHES HOWEVER, THERE WAS NO VIBRATE DURING THE SELF TEST AND THE PUMP WAS RECEIVED WITH HIGH SLEEP CURRENT. ACTIVATED AND DEACTIVATED THE VIBRATE FUNCTION FROM THE AUDIO OPTIONS AND VIBRATION SETTINGS MENU AND THE VIBRATOR DID NOT RESPOND. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS. A REVIEW OF THE PUMP HISTORY FILE REVEALS ON (B)(6) 2023 THERE WERE TWO (2) PUMP ERROR 3 (LINENUMBER 2771 FILENUMBER 124) MOTOR PROCESSOR COMMUNICATION ALARMS (06:37:19 AND 06:37:56) THAT OCCURRED. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO CORROSION AND MOISTURE DAMAGE WAS FOUND ON THE MOTOR, MOTOR FLEX TAIL, FORCE SENSOR, AND PCBA 1. PUMP ERROR 3 WAS GENERATED DUE TO IPC COMMUNICATION TIMEOUT: THE MAIN MCU DID NOT REPLY TO THE MOTOR IPC MESSAGE WITHIN THE TIMEOUT, HIGH SLEEP CURRENT, AND NO VIBRATION DURING THE SELF TEST/AUDIO OPTIONS DUE TO MOISTURE DAMAGE. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED SELECT BUTTON KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, SERIAL NUMBER LABEL FADED, AND CRACKED BATTERY TUBE THREADS. PUMP ERROR 3, HIGH SLEEP CURRENT, AND NO VIBRATION DURING THE SELF TEST/AUDIO OPTIONS ARE CONFIRMED DUE TO MOISTURE DAMAGE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED A PUMP ERROR 3 ALARM. IT IS REPORTED THAT THE CUSTOMER'S CONCERN OF THE PUMP IS VIBRATING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY, THE PUMP REWIND WAS COMPLETED AND THE CUSTOMER DID A SELF-TEST ON THE PUMP AND IT WAS NOT PASSED. THE CUSTOMER WILL DISCONTINUE PUMP USE AND REVERT TO THE BACKUP PLAN AS PER INSTRUCTIONS. THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899342 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG56FGC 000000763000283575

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other FRN-MMT-UNK-RSVR,UNK-INFSET